Shocking Therapy for Chronic Pelvic Pain Syndrome

NCT ID: NCT01828996

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2019-12-31

Brief Summary

Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis and accounts for approximately 2 million outpatient visits to urology practices in the United States alone. Up to 6% of men in Canada recently experienced at least moderate to severe prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There are a myriad of therapies for prostatitis, some of which work on some of the men but none works for all the men. Recently, a number of centres have been using low energy shock waves applied on the skin to target the prostate and the muscles around the prostate. The initial reports showed a significant reduction in the pain experienced by the men with prostatitis. However, this potentially highly promising therapy has not been widely used at least in part due to a lack of properly designed studies to validate this therapy. The investigators plan a randomized control trial using shock wave therapy on men with prostatitis. The goal is to provide some solid evidence that either shock waves are or are not of clinical benefit.

The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will have a reduction in pain and improved voiding and sexual function following low power transdermal shock wave therapy to the prostate and surrounding pelvic muscles.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Shock wave therapy

This group of patient will be treated with the shock wave head in the first 4 sessions then crossover to have the stand-off placebo for another 4 sessions.

Group Type: ACTIVE_COMPARATOR

Shock wave therapy

Intervention Type: DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.

Placebo

Intervention Type: DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region

Placebo

This group of patient will be treated with the stand-off placebo for the first 4 sessions then crossover to have the shock wave head in the other 4 sessions .

Group Type: PLACEBO_COMPARATOR

Shock wave therapy

Intervention Type: DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.

Placebo

Intervention Type: DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region

Interventions

Shock wave therapy

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.

Intervention Type: DEVICE

Placebo

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region

Intervention Type: DEVICE

Other Intervention Names

Storz Duolith SD1; Storz Duolith SD1 with stand-off head

Eligibility Criteria

Inclusion Criteria

• Exhibit symptoms of pain typical for prostatitis/CPPS
• Have had the symptoms for at least 3 months
• Have no evidence of infection in the urine or expressed prostatic secretions (the seminal plasma may be substituted if expressed prostatic secretions are not available).
• Have failed at least one therapy for CPPS

Exclusion Criteria

• Suspected or confirmed to have prostate cancer
• Have a coagulation disorders
• Use anticoagulants
• Have thrombosis
• Have used cortisone therapy up to 6 weeks before first treatment
• Are actively trying to conceive

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Jarvi, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CAN-SW-001

Identifier Type: -

Identifier Source: org_study_id